CN103096850A - Electrically evoked brainstem response measurements via implant prosthesis - Google Patents
Electrically evoked brainstem response measurements via implant prosthesis Download PDFInfo
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- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36036—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of the outer, middle or inner ear
- A61N1/36038—Cochlear stimulation
- A61N1/36039—Cochlear stimulation fitting procedures
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
- A61B5/0031—Implanted circuitry
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/316—Modalities, i.e. specific diagnostic methods
- A61B5/369—Electroencephalography [EEG]
- A61B5/377—Electroencephalography [EEG] using evoked responses
- A61B5/38—Acoustic or auditory stimuli
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
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- A—HUMAN NECESSITIES
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- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36128—Control systems
- A61N1/36135—Control systems using physiological parameters
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- A—HUMAN NECESSITIES
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- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/12—Audiometering
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/316—Modalities, i.e. specific diagnostic methods
- A61B5/369—Electroencephalography [EEG]
- A61B5/377—Electroencephalography [EEG] using evoked responses
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/48—Other medical applications
- A61B5/4851—Prosthesis assessment or monitoring
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
- A61B5/6868—Brain
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
- A61B5/7203—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0526—Head electrodes
- A61N1/0529—Electrodes for brain stimulation
- A61N1/0531—Brain cortex electrodes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0526—Head electrodes
- A61N1/0541—Cochlear electrodes
Abstract
A method of measuring electrically evoked auditory brainstem responses of a patient or animal body is provided. The method includes surgically implanting an auditory prosthesis having an electrode array, the electrode array positioned either intracochlear or substantially proximate a brainstem of the body. At least one electrode is stimulated in the electrode array. Electrically evoked auditory brainstem responses resulting from said stimulation are recorded using, at least in part, an electrode in the electrode array as a negative electrode, and a positive electrode positioned substantially proximate the vertex of the head of the body.
Description
Cross reference with related application
The application requires the priority of the U.S. Provisional Application submitted on July 29th, 2010 number 61/368,892, and described U.S. Provisional Application draws as reference take it in full at this.
Technical field
The present invention relates to the measurement of electrically evoked auditory brainstem response (eABR), more particularly relate to by the measurement of implanting prosthetic to eABR.
Background technology
The electrode of commercially available cochlear implant or auditory brainstem implant (ABI) system can be used for acute electricity irritation, obtains the important information about electrode itself and/or implant system, or records electricity and bring out current potential (EEP), for example compound action potential (CAP).Electricity bring out CAP reaction make it possible to measures CAP by cochlear implant and reacts.Yet, record the objective measurement value of various other types EEP by cochlea or ABI implant, still be a problem.
As the Katz J. that draws at this for reference, and Handbook of Clinical Audiology(" clinical audition handbook), Williams﹠amp; Wilkins, described in 1994, brings out current potential and comprises morning, neutralization listening property reaction incubation period in evening by the 4th edition.According to definition, CAP is the alternating current reaction by the cochlea end generation of cranial nerve,eighth, and it has represented the summation reaction of thousands of acoustic fibers synchronous discharges, as at Ferraro etc., The Use of Electrocochleography in the Diagnosis, Assessment, and Monitoring of Endolymphatic Hydrops(" application of electrocochleography in diagnosis, assessment and the monitoring of endolymphatic hydrops "), Otolaryngologic Clinics of North America, 16:1, pp.69-82, February nineteen eighty-three; With Hall J.W., Handbook of Auditory Evoked responses(" the AER handbook), Allyn and Bacon, Needham Heights, Massachusetts, described in 1992, its each draw in full as reference take it at this.Auditory brainstem response (ABR) is the signal of telecommunication (Katz, 1994) that brings out from the brain stem of people or other animals of presenting by signal specific.In the mankind, the first record of ABR current potential is by execution such as Jewett D.L., referring to Jewett D.L. etc., Human Auditory Evoked Potentials:Possible Brain Stem Components Detected on the scalp(" human auditory brings out current potential: the possible brain stem component that detects on scalp "), Science1970; 167:p.1517 – 8, draw in full as reference take it at this.The relatedness of the certain wave component of ABR and the component of Auditory Pathway can followingly represent: ripple I: cochlear action potential (CAP), far-end CNVIII; Ripple II: near-end CNVIII; Ripple III: cochlear nucleus; Ripple IV: upper superior olivary complex; And ripple V: lateral lemniscus.The definition at peak is described in Jewett D.L. etc., Auditory-evoked Far Fields Averaged from the scalp of Humans(" from the average far field of bringing out audition of mankind's scalp "), Brain.1971; 94 (4): p.681-96, draw in full as reference take it at this.
Electrically evoked auditory brainstem response (eABR) can obtain by partly recording a series of current potentials with one or more scalp electrodes.Reaction typically occurs in 10msec after the impulse stimulation outbreak.Impulse stimulation can for example be provided by the electrode that is associated with cochlear implant or ABI.
In many cases, electrically evoked auditory brainstem response (eABR) can provide the information that can be used for implant.For example, eABR can provide the important information about audition, and uses particular stimulation may provide the electrode specificity of object to listen force information.Although CAP measures the information that can obtain about nerve fiber in cochlea, eABR has the ability of the various brain functioies of the lower part that checks Auditory Pathway, the function of namely assessing internal ear, cranial nerve,eighth and auditory system.
EABR for by ABI directly is placed in electrod-array on cochlear nucleus.Therefore, eABR record can not comprise the record of ripple I, II and subwave III, and with use cochlear implant to compare to occur getting 1-2ms early.Owing to presenting stimulus artifact during basically at once and at recording start after stimulating presenting, therefore analyzes eABR by ABI typically difficult than carry out the eABR analysis by cochlear implant.In adaptation procedure, for the ABI object that never hears about or only have considerably less audition use experience (for example child), eABR becomes very important objective measurement approach.The patient compares with cochlear implant, and eABR may be even more important to ABI patient, and this is due in the cochlear implant patient, in adaptation procedure more normally used objective measurement approach, be that electricity brings out stapedial reflex measurement method (eSR), possibly can't cause.
The specific use of eABR is following listed.
-eABR can be used for that assist electrode is placed and the operation of implant function in or confirmation after operation (referring to Behr R. etc., The High Rate CIS Auditory Brainstem Implant for Restoration of Hearing in NF-2 Patients(is used for recovering NF-2 patient the two-forty CIS auditory brainstem implant of audition), Skull.Base17 (2), 2007, p.91-107; And Bahmer A. etc., Recording of Electrically Evoked Auditory Brainstem Responses (E-ABR) with an Iintegrated Stimulus Generator in Matlab(uses the integrated stimulation maker in Matlab to record electrically evoked auditory brainstem response (E-ABR)), Journal Neuroscience Methods173 (2), 2008, p.306-314, its each this take its draw in full as with reference to).EABR has become the canonical measure method for the correct placement of judgement electrode blade on cochlear nucleus.
-eABR can be used for the diagnostic assessment of assisting patients (referring to Gibson etc., The Use of Intra-operative Electrical Auditory Brainstem Responses to Predict the Speech Perception Outcome after Cochlear Implantation(uses the voice after the interior electric auditory brainstem response prediction cochlea of operation is implanted to experience result), Cochlear.Implants Int., 10Suppl12009, p.53-57, draw in full as reference take it at this).Particularly, eABR can be used as the instrument of assessment and monitoring audition, otology and neurological disorder (being the acoustics tumor monitoring).
-eABR can be used for assisting programming after the operation of implantable hearing devices, particularly the patient who is difficult to install such as the child in (referring to Brown C.J. etc., The relationship between EAP and EABR thresholds and levels used to program the nucleus 24speech processor:data from adults(EAP and EABR threshold value and be used for relatedness between the level of programming core 24 speech processors: the data that come from the adult), Ear Hear.21 (2), 2000, with McMahon etc., 2008, p.151-163, and McMahon C.M. etc., Frequency-specific Electrocochleography Indicates that Presynaptic and Postsynaptic Mechanisms of Auditory Neuropathy Exist(specific frequency electrocochleography shows presynaptic and the postsynaptic mechanisms that Auditory neuropathy exists), Ear Hear.29 (3), 2008, p.151-163, its each this take its draw in full as with reference to).
-eABR can provide about in each cochlea or the additional information of the psychoacoustics threshold value of electrode (referring to Brown etc., 2000).
-eABR can be used for assisting to provide quantitative information about Auditory Pathway (referring to Polak M. etc., Evaluation of Hearing and Auditory Nerve Function by Combining ABR, DPOAE and eABR Tests into a Single Recording Session(assesses audition and acoustic nerve function by ABR, DPOAE and eABR test is incorporated in single record slot), J.Neurosci.Methods134 (2), 2004, p.141-149; And Gibson etc., 2009).
It may be loaded down with trivial details obtaining eABR.Need in typical case the external system for record, then it must be joined/synchronize with stimulating system.Various recording electrodes need to be placed on the patient, its position may be subject to the impact that the patient moves.
In addition, commercially available recording system is usually with stimulus artifact record together with physiological reaction.These artefacts may be more much higher than physiological reaction (artefact is higher nearly tens times than physiological reaction).Therefore, usually be very difficult to judge whether to exist physiological reaction.Sometimes, artefact is obscured mutually with physiological reaction, so the final deciphering of result may produce incorrect deciphering.For measuring in operation, when only depending on the eABR reaction, unsuitable judgement may have very noticeable impact to performance after the operation of using implant system.For eABR record, only have at present alternately that the artefact removing method commercially uses (such as referring to Polak etc., 2004).Yet this method is usually unsatisfactory aspect the elimination stimulus artifact.
Summary of the invention
A kind of method of electrically evoked auditory brainstem response of the body for measuring patient or animal is provided according to a first aspect of the invention.Described method comprises the audition prosthese that has electrod-array by Operation, and described electrod-array is placed in cochlea or the brain stem placement of contiguous described body substantially.At least one electrode in described electrod-array is stimulated.Use at least in part and can as the scalp of the electrode in the described electrod-array of negative electrode and the described body of vicinity that can be used as anelectrode and/or the electrode of forehead placement, record the electrically evoked auditory brainstem response that is caused by described stimulation.
According to related embodiment of the present invention, described audition prosthese can be brain stem implant or cochlear implant.The described electrode that the scalp of contiguous described body and/or forehead are placed can be placed in the outside or inner of described body.The described electrode that the scalp of contiguous described body and/or forehead are placed can substantially be close to the crown of described body and place.The described electrode that the scalp of contiguous described body and/or forehead are placed can with the coupling of described audition prosthetic procedure.Described audition prosthese can comprise adapter, and described method comprises that also the described electrode with the scalp of contiguous described body and/or forehead placement is connected with described audition prosthese by described adapter.Can when implanting described audition prosthese, described adapter be placed in described body, and when the described electrode that the scalp that will be close to described body and/or forehead are placed is connected with described audition prosthese by described adapter, the described electrode that is close to the scalp of described body and/or forehead placement is placed in inside or the outside of described body.Described at least one electrode in described electrod-array can only be used for record, perhaps be used for record and stimulate (namely playing the effect of audition prosthese) both.Stimulate at least one electrode in described electrod-array, can comprise a plurality of electrodes that stimulate in described electrod-array.
According to other related embodiment of the present invention, described method can comprise from described reaction eliminates artefact.Eliminate artefact and comprise improved forward masking elimination from described reaction.
According to another embodiment of the invention, a kind of system of electrically evoked auditory brainstem response of the body for measuring patient or animal comprises: the audition prosthese, it has electrod-array, and described electrod-array is used for being placed in cochlea or the brain stem placement of contiguous described body substantially.Electrode, it can be used as anelectrode, and with the coupling of described audition prosthetic procedure, the scalp and/or the forehead that are used for contiguous described body are placed.Controller, it is used for stimulating at least one electrode of described electrod-array, and use at least in part and can and be used for the scalp of contiguous described body and/or the described electrode that forehead is placed as the electrode in the described electrod-array of negative electrode, record the electrically evoked auditory brainstem response that is caused by described stimulation.
According to related embodiment of the present invention, described audition prosthese can be brain stem implant or cochlear implant.Described audition prosthese can comprise be used to the adapter that is connected to the described electrode of placing for scalp and/or the forehead of contiguous described body.Described adapter can be coupled to described audition prosthese removedly with being used for the scalp of contiguous described body and/or the described electrode of forehead placement.Described adapter can be included in when implanting described audition prosthese for the device that described adapter is placed in described body.At least two electrodes described controller can stimulate described electrod-array simultaneously when measuring electrically evoked auditory brainstem response in.
According to other related embodiment of the present invention, described controller can be eliminated the artefact in described reaction.Described controller can utilize improved forward masking to eliminate artefact.
According to another embodiment of the invention, provide a kind of method of electrically evoked auditory brainstem response of the body for measuring patient or animal.Described method comprises the audition prosthese that has electrod-array by Operation, and described electrod-array is placed in cochlea or substantially is close to the brain stem of described body.At least one electrode in described electrod-array is stimulated.The electrically evoked auditory brainstem response that record is caused by described stimulation.Use the artefact in the described reaction of improved forward masking method elimination.
According to other related embodiment of the present invention, record anelectrode that described electrically evoked auditory brainstem response can comprise that at least in part the scalp that uses contiguous described body and/or forehead are placed and the negative electrode of a kind of position placement in mastoid process, ear-lobe and the ear forefoot area of contiguous ear substantially.Described anelectrode and negative electrode can be placed in described external body, and can be for example surface electrode and/or needle electrode.Can use ground electrode, and for example can be placed on the forehead of bottom.
According to other related embodiment of the present invention, record the electrode that plays the negative electrode effect in anelectrode that described electrically evoked auditory brainstem response can comprise that at least in part the scalp that uses contiguous described body and/or forehead are placed and described electrod-array.Described anelectrode can be coupled to described audition prosthese by the adapter operability.Described anelectrode can be placed in inside or the outside of described body.Stimulate at least one electrode in described electrod-array can comprise a plurality of electrodes that stimulate in described electrod-array.
The accompanying drawing summary
By with reference to following detailed description and with reference to accompanying drawing, can more easily understand These characteristics of the present invention, in described accompanying drawing:
Fig. 1 (a) is the block diagram for the conventional system of measuring eABR;
Fig. 1 (b) shows for the typical recording electrode of eABR and places;
Fig. 2 shows the eABR measuring system that meets embodiment of the present invention;
Fig. 3 (a-c) shows exemplary ABR and eABR waveform;
Fig. 4 shows the improved forward masking scheme that is used for being applied to the eABR measurement of embodiment according to the invention.
The detailed description of specific embodiments
In exemplary of the present invention, provide the system and method for the electrically evoked auditory brainstem response (eABR) of the body that is used for measurement patient or animal.In general, use (for example as negative electrode) one or more electrodes and contiguous patient's scalp or (for example as the anelectrode) electrode that forehead is placed in the electrod-array of cochlea or auditory brainstem implant, record electrically evoked auditory brainstem response.Such structure advantageously increases the wave amplitude of the eABR that is recorded to.In various embodiments, the artefact that exists in eABR is advantageously eliminated with the forward masking method, and/or the measurement of eABR can carry out with prosthese, and need not use the recording system of separation.Details is discussed below.
Fig. 1 (a) is the block diagram for the system of the eABR of the body of measuring patient or animal.System comprises control module 101, and it partly has stimulating module 105 and logging modle 107.Stimulating module 105 provides to prosthese (for example cochlear implant or ABI) stimulates input 109, and trigger message is transferred to logging modle 107.The outside of system and the communication between interior section, can but be not limited to by the Percutaneous radiofrequency ablation link, it typically comprises and the interactive external coil 111 of the Inside coil of implant.Recording electrode 113 gathers eABR, then it is processed in logging modle 107.As shown in Figure 1 (b), the conventional recording electrode position that is used for eABR, can include but not limited to be placed in the active anelectrode 120 on the crown (Cz) and/or forehead, and/or the homonymy that is placed in ear carried out the active negative electrode 121 on mastoid process, ear-lobe or ear forefoot area that implantation or offside do not carry out implanting.Benchmark/ground electrode 122 can be placed in neck, bottom forehead or shoulder upper (referring to for example, Katz etc., 1994).
In exemplary of the present invention, the measurement of eABR is undertaken by the prosthese of implanting, and does not need the external record module of separating.Fig. 2 shows the eABR measuring system according to embodiment of the present invention.System comprises implant 201, and it can be cochlear implant or ABI, but is not limited to this.Implant 201 comprises electrod-array 209, is used for but is not limited to (in order to stimulating acoustic nerve) or the brain stem placement of neighbouring body substantially in cochlea.
Except electrod-array, various (one or more) recording electrode 211 is connected with implant 201.Can use cable/wire 213 known in the art that (one or more) recording electrode 211 is connected to implant 201.Cable/wire can be but be not limited to flexibility, adjust in the placement of electrode 211 with permission.
(one or more) recording electrode 211 can be connected to implant 201 removable and/or non-removablely.In various embodiments, one or more recording electrodes 211 can be complete implantable ground/be connected to implants 201 in position and non-removablely.In other embodiments, implant 201 can comprise (one or more) adapter 205, and it is used in operation, one or more recording electrodes 211 being coupled to implant 201.In various embodiments, plug is placed in patient inside.After measuring in operation for example, then can (one or more) electrode 211(crown electrode for example) disconnection, and implant can be kept somewhere in body together with adapter 205.(one or more) recording electrode 211 can be surface or needle electrode, and it places (on skin or just under skin) in operation, and is connected to implant 201 by adapter 205.After bringing out potential measurement, then can remove (one or more) electrode 211.In optional embodiment, adapter can be placed in the patient outside.
In various embodiments of the present invention, electrode 211, such as but not limited to anelectrode can be placed on patient's scalp or forehead or just under it.For example, electrode 211 can be placed in the top of patient's head/place, top.In addition, (be used for cochlear implant) or an electrode of the electrod-array 209 of contiguous auditory brainstem (the being used for ABI) implant of placing substantially, can be used as negative electrode, but be not limited to this in cochlea.This structure and former structure ratio, advantageously (and surprisingly) provide more that the eABR of robustness measures.Negative electrode 209 can be the electrode that has existed in the implant electrod-array, in order to use it for stimulation between the normal operating period of implant, and is used for record when measuring eABR.Alternatively, negative electrode 209 can be not used in stimulation, therefore may need to be added to the existing electrod-array structure of implant.According to a further embodiment of the present invention, can for example use and be placed near for example negative electrode of mastoid process shown in Fig. 1 (a), implant is attached to more conventional recording electrode structure.
When carrying out the eABR measurement, can activate single electrode channel.Alternatively, according to various embodiments of the present invention, can activate simultaneously a plurality of electrode channels.For example, can activate simultaneously the interior a plurality of electrodes of electrod-array of cochlear implant or ABI.Stimulate with single channel and compare, activating simultaneously a plurality of electrodes during eABR advantageously needs the electric current of each lower electrode channel just can bring out reaction.Therefore, using stimulates the eABR that carries out to measure simultaneously, may be helpful needing high current in causing the object of Auditory Perception.In addition, stimulate simultaneously during eABR and bring out the reacting phase ratio with stimulating to measure with single channel, allow generally installation process (being to reduce the set-up time) faster.The approximate installation diagram that installation diagram may be also produces from the record of same quantity when using that only single channel stimulates is more accurate.In the patient who is difficult to install, the reacting phase ratio the when reaction that the use multichannel stimulates stimulates with the use single channel generally has more robustness and more easily identification.
Except above-mentioned eABR embodiment or with the combination of above-mentioned eABR embodiment, all that stimulate the installation that can advantageously be applied to can be used for implanting prosthetic in the time of electrode are brought out electric potential method.Such method can include but not limited to: early bring out auditory response (for example eABR) incubation period; Middle latency brings out auditory response (for example MLR, 40Hz) or brings out auditory response (for example P300, P1N1P2) late period and muscle reflex response (for example PAMR).
Illustrative methods/the embodiment of the multichannel stimulation of bringing out current potential/muscle reflection that is used for mounting implant is described now.Method can be applicable to install any current potential process of bringing out of implanting prosthetic.
1. select the number of channels n that to stimulate simultaneously.Selected electrode should be in order; For example, if n=3, stimulating electrode 1-3, follow by electrode 4-6, electrode 7-9, electrode 10-12 ...
2. measure eABR reaction (increasing irritation level until observe reaction clearly).
3. the irritation level when reducing irritation level and determining objective loss for reaction.Irritation level during this objective loss for reaction is called as threshold value benchmark (TR).For eABR, usually observe ripple 5, because it is robustness.Fig. 3 (a-c) shows exemplary ABR and eABR waveform.More particularly, Fig. 3 (a) shows example acoustic and brings out ABR; Fig. 3 (b) shows the exemplary electrical of cochlea implantation object and brings out ABR; And Fig. 3 (c) electricity of showing the ABI object brings out the example of ABR.
4. determine the average maximum comfortable level (MCL) of selected electrode group.The average MCL of selected electrode group can but be not limited to calculate according to formula TR/0.6n.
5. determine the average threshold (T) of selected electrode group.Average T can but be not limited to approx to calculate (25% of MCL, or less 4 times than MCL) according to formula TR/2.4n.
6. select next the group electrode (electrode ((n+1 ..., 2n) and repeating step 2-5.For example, if n=3 selects electrode 4,5 and 6.
7. after all electrodes have all been selected, stop measuring.
8. be that each single electrode is determined approximate MCL.Use linear approximation method, approximate MCL can according to but be not limited to calculate according to following formula:
The n=4(even number)
F1MCL＝MCLGroup1+(n/2)*(MCLGroup1-MCLGroup2)/n
E2MCL＝MCLGroup1+(n/2-1)*(MCLGroup1-MCLGroup2)/n
E3MCL＝MCLGroup1-(n/2-1)*(MCLGroup1-MCLGroup2)/n
E4MCL＝MCLGroup1-(n/2)*(MCLGroup1-MCLGroup2)/n
E5MCL＝MCLGroup2+(n/2)*(MCLGroup1-MCLGroup2)/n
E6MCL＝MCLGroup2+(n/2-1)*(MCLGroup1-MCLGroup2)/n
E7MCL＝MCLGroup1-(n/2-1)*(MCLGroup2-MCLGroup3)/n
E8MCL＝MCLGroup1-(n/2)*(MCLGroup2-MCLGroup3)/n
·
·
·
The n=3(odd number)
E1MCL＝MCLGroup1+(MCLGroup1-MCLGroup2)/3
E2MCL＝MCLGroup1
E3MCL＝MCLGroup1-(MCLGroup1-MCLGroup2)/3
E4MCL＝MCLGroup2+(MCLGroup1-MCLGroup2)/3
E5MCL＝MCLGroup2
E6MCL＝MCLGroup2-(MCLGroup2-MCLGroup3)/3
·
·
·
For each single electrode is determined approximate threshold value T.Use linear approximation method, approximate T can according to but be not limited to calculate according to following formula:
The n=4(even number)
E1T＝TGroup1+(n/2)*(TGroup1-TGroup2)/n
E2T＝TGroup1+(n/2-1)*(TGroup1-TGroup2)/n
E3T＝TGroup1-(n/2-1)*(TGroup1-TGroup2)/n
E4T＝TGroup1-(n/2)*(TGroup1-TGroup2)/n
E5T＝TGroup2+(n/2)*(TGroup1-TGroup2)/n
E6T＝TGroup2+(n/2-1)*(TGroup1-TGroup2)/n
E7T＝TGroup1-(n/2-1)*(TGroup2-TGroup3)/n
E8T＝TGroup1-(n//2)*(TGroup2-TGroup3)/n
·
·
·
The n=3(odd number)
E1T＝TGroup1+(TGroup1-TGroup2)/3
E2T＝TGroup1
E3T＝TGroup1-(TGroup1-TGroup2)/3
E4T＝TGroup2+(TGroup1-TGroup2)/3
E5T＝TGroup2
E6T＝TGroup2-(TGroup2-TGroup3)/3
·
·
·
In various embodiments, can not calculate the T level, perhaps can for example obtain the T of each electrode according to T=.1 (MCL).The electrode that above-mentioned formula hypothesis is just being stimulated correctly is inserted in cochlea.If any electrode breaks down or outside cochlea, these electrodes should be excluded and avoid stimulating, and therefore MCL and T calculating is adjusted.Said method is applicable to eCAP, and TR is defined as causing the maximal stimulus level of CAP reaction in this case.The calculating of MCL and T may need suitably to adjust, to take various types of analog in nature of implanting prosthetic into account.In various embodiments, the constant value 0.6 and 2.4 in the calculating of MCL group (TR/0.6n) and T group (TR/2.4n) may be different for the Different electrodes array.
In other exemplary of the present invention, will eliminate by the artefact that the subduction method is carried out and be applied to eABR calculating.In preferred embodiments, can utilize what is called " improved forward masking method ", it is with similar for the method that records the CAP reaction, but never being applied in the past eABR calculates (referring to Miller C.A. etc., An improved method of reducing stimulus artifact in the electrically evoked whole-nerve potential(reduces electricity and brings out improving one's methods of stimulus artifact in full neuropotential), Ear Hear.2000Aug; 21 (4), in Fig. 2 p.280-90, described document this draw be with reference to).The eCAP record is responsive to the artefact of stimulus artifact, electrode or implant artefact and miogenic type.Except the artefact of above-mentioned eCAP, eABR is to very responsive by patient's (being patient's movement) and the caused artefact of surrounding thereof.Above-mentioned embodiment allows more stable electrode to place (particularly recording electrode implanted or embodiment in position otherwise), causes using the subduction method to be eliminated more favourable.
Fig. 4 has shown " improved forward masking " scheme that is used for being applied to the eABR measurement according to embodiment of the present invention.Should be appreciated that, also can utilize other mathematics artefact removing methods known in the art, for example the forward masking method of subthreshold value template method or standard.Illustratively, with reference to figure 4, separately the situation of probe is not recorded (hypothesis that the form of the EAP that therefore, no longer need to shelter part and the form of not sheltering EAP are equal to) in the forward masking method of standard.On the contrary, obtain direct measurement to the EAP of masked probe with various shelter-probe separation.In Fig. 4, trace B has shown the stimulation that causes the reaction of part refractoriness.As shown in trace E, the shelter-probe separation that has an absolute refractoriness (E) by use records the probe of forward masking, reduces the probe artefact in B.Stimulate in order to eliminate the shelter of introducing in B and E, utilized the record of the shelter reaction C ' of shelter reaction C and time-shift.Waveform (the R that obtains
2) equal B-E-C+C ', eliminated the probe stimulus artifact.
Use the above-mentioned advantage that has for the implant recording system of the electrode of CI and ABI object to comprise: improved artefact is eliminated; To the less scanning of each record, cause the record of the minimizing of clinical time/faster; The recording electrode structure of the eABR record of describing in the above-described embodiment will reduce the artefact that is caused by patient's (being that the patient moves), particularly in the situation that use fixed electrode; Lower to possible error sensitivity, particularly when stimulating and the recording electrode time-object that has the fixed position will have the freedom of more movements during measuring; And it more easily carries out (do not need the external record system, do not need recording system is connected with stimulating system, and need not place recording electrode (in electrode embodiment in position)).
Should be appreciated that, the electricity that above-mentioned embodiment can be used for other types brings out current potential (EEP) measurement (auditory response incubation period in evening for example comprises early, neutralizes), yet, depend on just measured EEP type, the placement of recording electrode may be different with quantity.For example, when measurement current potential incubation period in evening, can add other Cz electrodes.
Embodiment of the present invention can all or part of conduct use together with computer system computer program realize.Such realization can comprise the instruction of series of computation machine, it is fixed on tangible media for example on computer-readable medium (for example floppy disk, CD-ROM, ROM or hard disk), maybe can for example be transferred to computer system via the communication adapter that medium is connected to network by modem or other interface equipments.Described medium can be tangible media (for example optics or analog communication line) or the medium that uses wireless technology (for example microwave, infrared or other transmission technologys) execution.The instruction of described series of computation machine has been implemented above to the described all or part function of system.The professional of the art should be realized that, such computer instruction can be write as the multiple programming language that uses together with many Computer Architectures or operating system.In addition, such instruction can be stored in any memorizer for example in quasiconductor, magnetic, light or other memorizeies, and can for example light, infrared, microwave or other transmission technologys are transmitted with any communication technology.Estimate that such computer program can be used as with printing or the removable media of electronic document (for example compressing software packaging) and distribute, be contained in advance in computer system (for example on the ROM or hard disk of system) or server or BBS from network (for example internet or WWW) and distribute.Certainly, certain embodiments of the present invention combination of can be used as software (for example computer program) and hardware is carried out.Other embodiments of the present invention are carried out as devices at full hardware or full software (for example computer program).
The purpose of above-described embodiment of the present invention is only exemplary; For the professional of the art, it will be apparent changing in a large number and revise.The variation that all are such and modification are planned to be included within the scope of the present invention.
Claims (27)
1. the method for the electrically evoked auditory brainstem response of a body that be used for to measure patient or animal, described method comprises:
The audition prosthese that has electrod-array by Operation, described electrod-array are placed in a kind of position in cochlea brain stem interior and contiguous described body substantially;
Stimulate at least one electrode in described electrod-array; And
Use at least in part electrode and the scalp of contiguous described body and/or the electrode that forehead is placed in described electrod-array, record the electrically evoked auditory brainstem response that is caused by described stimulation.
2. according to claim 1 method, wherein said audition prosthese are a kind of in brain stem implant and cochlear implant.
3. according to claim 1 method, wherein said audition prosthese comprises adapter, described method also comprises:
Described electrode, at least one electrode of described body are connected with described audition prosthese by described adapter.
4. according to claim 3 method also comprises:
When implanting described audition prosthese, described adapter is placed in described body, and when the electrode of wherein placing at the scalp that will be close to described body and/or forehead is connected with described audition prosthese by described adapter, the electrode that is close to the scalp of described body and/or forehead placement is placed in inside and outside both a kind of position of described body.
5. according to claim 1 method comprises that also the electrode that scalp and/or the forehead of contiguous described body are placed implants in described body, described electrode and the coupling of described audition prosthetic procedure that the scalp of contiguous described body and/or forehead are placed.
6. according to claim 1 method, also comprise from reaction and eliminate artefact.
7. according to claim 6 method is wherein eliminated artefact and is comprised that improved forward masking eliminates from described reaction.
8. according to claim 1 method, wherein said at least one electrode only is used for record.
9. according to claim 1 method, described at least one electrode of placing of the scalp of contiguous described body and/or forehead is wherein placed by the crown of contiguous described body substantially.
10. according to claim 1 method, at least one electrode in the described electrod-array of its moderate stimulation comprises a plurality of electrodes that stimulate in described electrod-array.
11. method according to claim 1, described at least one electrode in wherein said electrod-array is used as negative electrode, and the described electrode of the scalp of contiguous described body and/or forehead placement is used as anelectrode.
12. the system for the electrically evoked auditory brainstem response of the body of measuring patient or animal, described method comprises:
The audition prosthese, it has electrod-array, and described electrod-array is used for being placed in cochlea and substantially is close to a kind of position of the brain stem of described body;
Electrode, itself and the coupling of described audition prosthetic procedure, the scalp and/or the forehead that are used for contiguous described body are placed; And
Controller, it is used for stimulating at least one electrode of described electrod-array, and use at least in part the electrode in described electrod-array and be used for the scalp of contiguous described body and/or the described electrode that forehead is placed, record the electrically evoked auditory brainstem response that is caused by described stimulation.
13. system according to claim 12, wherein said audition prosthese is a kind of in brain stem implant and cochlear implant.
14. system according to claim 12, wherein said audition prosthese comprises be used to the adapter that is connected to the described electrode of placing for scalp and/or the forehead of contiguous described body.
15. according to right. require 14 system, the coupling removedly of wherein said adapter is used for the described electrode of contiguous described scalp and/or forehead placement.
16. system according to claim 14, wherein said adapter is included in when implanting described audition prosthese for the device that described adapter is placed in described body.
17. system according to claim 12, wherein said controller is eliminated the artefact in described reaction.
18. system according to claim 17, wherein said controller utilizes improved forward masking to eliminate artefact.
19. system according to claim 12, at least two electrodes wherein said controller stimulates described electrod-array simultaneously when measuring electrically evoked auditory brainstem response in.
20. system according to claim 12, described at least one electrod-array in wherein said electrod-array is used as negative electrode, and the described electrode of placing for scalp and/or the forehead of contiguous described body is used as anelectrode.
21. the method for the electrically evoked auditory brainstem response of the body of measuring patient or animal, described method comprises:
The audition prosthese that has electrod-array by Operation, described electrod-array are placed in a kind of position in cochlea brain stem interior and contiguous described body substantially;
Stimulate at least one electrode in described electrod-array;
The electrically evoked auditory brainstem response that record is caused by described stimulation; And
Use the artefact in the described reaction of improved forward masking method elimination.
22. method according to claim 21 wherein records described electrically evoked auditory brainstem response and comprises: the negative electrode of a kind of placement in mastoid process, ear-lobe and the ear forefoot area of the anelectrode that the scalp of the described body of use vicinity at least in part and/or forehead are placed and the ear of contiguous described body.
23. method according to claim 22, wherein said anelectrode and negative electrode are a kind of in surface electrode and needle electrode.
24. method according to claim 21 wherein records described electrically evoked auditory brainstem response and comprises: the electrode that plays at least in part the negative electrode effect in the anelectrode of the scalp of the contiguous described body of use and/or forehead placement and described electrod-array.
25. method according to claim 21 also comprises at least one anelectrode is coupled to described audition prosthese by the adapter operability.
26. method according to claim 21 also comprises at least one anelectrode is placed in described body.
27. method according to claim 21, at least one electrode in the described electrod-array of its moderate stimulation comprise a plurality of electrodes that stimulate in described electrod-array.
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| EP (2) | EP2598092B1 (en) |
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| WO2012016138A1 (en) | 2012-02-02 |
| EP2598092B1 (en) | 2018-12-05 |
| US20120029377A1 (en) | 2012-02-02 |
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| US8768448B2 (en) | 2014-07-01 |
| US9616232B2 (en) | 2017-04-11 |
| AU2011282501B2 (en) | 2014-08-07 |
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| CN103096850B (en) | 2016-08-03 |
| AU2011282501A1 (en) | 2013-02-07 |
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